The pump has not been returned to animas for evaluation.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.This report is made under the requirements of the medical device reporting regulations and does not constitute an admission on the part of animas of any deficiency in the performance of the device.Follow-up # 1 date of submission 04/09/2015.Device evaluation: the pump has been returned and evaluated by product analysis on 03/31/2015 with the following findings: a review of the pump¿s black box history showed that power reboots were recorded on 02/04/2015.Visual inspection revealed that the battery compartment threads were damaged.The battery compartment was also found to be cracked in the thread area and blow the grip pad.The returned battery cap was not able to be secured to the pump and was unable to maintain an electrical connection with the pump.A test battery cap was used to complete all testing.The pump was exercised for 24 hours with no power reboots, power losses, or call service alarms occurring.The pump case was removed and no evidence of moisture or loose components was found inside the pump.This report is made under the requirements of the medical device reporting regulations and does not constitute an admission on the part of animas of any deficiency in the performance of the device.
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On (b)(6) 2015, the reporter contacted animas, alleging a power (damage) issue.The reporter alleged that the pump was losing power intermittently.It was noted that the battery compartment threads were stripped and the battery cap was not able to be secured appropriately to the pump.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.
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